The complexity of medical devices has increased over the past 10 years, and outbreaks of infections due to contaminated devices have focused attention on the need to adequately clean medical devices in order to ensure the adequacy of disinfection and sterilization. There has been a paradigm shift in reprocessing of medical devices, with increased emphasis on a quality management systems approach that requires validated cleaning instructions from manufacturers and ongoing monitoring by reprocessing personnel to ensure adequacy of cleaning.
過去10年中醫(yī)療器械復(fù)雜程度顯著提升，同時(shí)也導(dǎo)致了器械污染導(dǎo)致的感染事件的增加。人們開始意識(shí)到有必要對(duì)醫(yī)療器械進(jìn)行充分清潔，以確保充分的消毒和滅菌。醫(yī)療器械回收過程越來越強(qiáng)調(diào)質(zhì)量管理體系方法，要求制造商提供經(jīng)過驗(yàn)證的清潔指示，并進(jìn)行持續(xù)監(jiān)測(cè)，以確保清洗的充分性。
Reusable medical devices are designed to be used repeatedly on patients,and the manufacturer’s instructions for use (MIFU) must include specific, validated instructions for cleaning as well as for disinfection and/or sterilization. If medical devices are not properly reprocessed, there is a risk that they will be contaminated with microorganisms that could be transmitted to multiple patients, causing colonization or infections.
復(fù)用醫(yī)療器械是指設(shè)計(jì)為在不同病人之間重復(fù)使用的醫(yī)療器械，而在重復(fù)使用前必須經(jīng)過恰當(dāng)?shù)娜ノ鄣忍幚砹鞒?。制造商的使用說明(MIFU)必須包括具體的、經(jīng)驗(yàn)證的清洗、消毒和/或滅菌方法。若處理不當(dāng)，易造成感染。
As awareness of infection transmission through contaminated medical devices increases, it is becoming increasingly apparent that a quality management systems (QMS) approach is needed, regardless of the type of medical device being processed. A QMS approach has been defined as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization;s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.” The quality monitoring processes for sterilization technologies are well established; however, for highlevel disinfectant (HLD) processes, only recently have quality monitoring processes been introduced that go beyond just checking reusable HLDs to ensure a minimal effective concentration. Despite this progress, there has been little in the way of establishing quality monitoring of manual or automated cleaning efficacy for any type of reusable medical device, despite the recognition that disinfection and sterilization processes will fail if the cleaning has not been performed adequately.
隨著人們?cè)絹碓揭庾R(shí)到污染醫(yī)療器械造成的感染，質(zhì)量管理體系(QMS)的必要性也越來越明顯。質(zhì)量管理體系是指：為實(shí)現(xiàn)質(zhì)量方針和目標(biāo)而記錄過程、程序和責(zé)任的一種形式化的系統(tǒng)。質(zhì)量管理體系有助于協(xié)調(diào)和指導(dǎo)組織的活動(dòng)，以滿足客戶和法規(guī)的要求，并持續(xù)改進(jìn)其有效性和效率。滅菌過程的質(zhì)量監(jiān)測(cè)已經(jīng)建立，但高水平消毒引入質(zhì)量監(jiān)測(cè)的時(shí)間較短，僅保證連續(xù)使用過程中其有效濃度不低于最低有效濃度。盡管人們已經(jīng)認(rèn)識(shí)到了如果清潔工作不充分可能導(dǎo)致消毒和滅菌的失敗，但復(fù)用醫(yī)療器械的手工或自動(dòng)清洗效果質(zhì)量監(jiān)測(cè)仍然很少。
The microbial load on patient-used surgical instruments is relatively low. The microbial levels varied depending on the type of surgery, with cesarean section surgery showing the highest CFU/cm2.Significantly fewer organisms were detected from clean-contaminated vs contaminated surgeries (average of 41±84 CFU/device vs 201±126 CFU/device), and infected surgical procedures were found to have the highest level of contamination. The most common microbes detected from surgical instruments used for clean orthopedic surgery were coagulase-negative staphylococci, Staphylococcus aureus, and Bacillus spp. Detection of Gram-negative bacteria increased in clean-contaminated and infected orthopedic surgery, but the predominant isolates were still Staphylococcus and Bacillus spp., a finding similar to data from other published studies. Although surgical instruments typically have low microbial levels, the level of organic residuals is high, and inadequate removal of patient secretions, tissue, and bone, for example, may result in failure of the sterilization process. These findings emphasize the importance of the cleaning process to ensuring adequate sterilization.
使用后的器械上微生物負(fù)荷相對(duì)不高，且與外科手術(shù)類型有關(guān)。剖腹手術(shù)器械上的CFU數(shù)值最高（CFU/cm2）。清潔-污染手術(shù)器械上檢測(cè)到的有機(jī)物顯著少于污染手術(shù)，感染手術(shù)器械的污染程度最高。清潔骨科手術(shù)器械上最常見的微生物是凝固酶陰性葡萄球菌，清潔-污染手術(shù)和感染手術(shù)器械上革蘭氏陰性細(xì)菌較多，但主要還是葡萄球菌和芽孢桿菌。盡管手術(shù)器械的微生物含量通常很低，但有機(jī)殘留物的含量卻很高，而且對(duì)患者分泌物、組織和骨骼等的去除不充分可能導(dǎo)致滅菌過程失敗。這些發(fā)現(xiàn)強(qiáng)調(diào)了清洗過程對(duì)確保充分滅菌的重要性。
Medical devices are cleaned manually as well as by automated washers. The current ANSI/AAMI ST79 guideline supports the efficacy of automated washer-disinfectors (WDs) for reprocessing the majority of surgical instruments (often with sonication before cleaning in the WD). The automation of cleaning ensures that the process will be reproducibly performed and done more efficiently than manual cleaning, and the WD provides thermal decontamination of instruments which reduces the infection risk to reprocessing personnel who then handle the instruments for packaging and sterilization.
醫(yī)療器械通常用手洗或者機(jī)洗處理。ANSI/AAMI ST79肯定了自動(dòng)清洗消毒機(jī)對(duì)大多數(shù)手術(shù)器械再處理的有效性(通常在機(jī)洗前進(jìn)行超聲處理)。洗消機(jī)的運(yùn)用提高了器械處理效率，同時(shí)，對(duì)器械進(jìn)行熱消毒，減少了操作人員的感染風(fēng)險(xiǎn)。
The adequacy of cleaning of medical devices can be evaluated by monitoring the WD when automated methods are used or by monitoring the cleaned device itself. Current guidelines recommend that monitoring the cleaning efficacy in WDs should be performed at least weekly, preferably daily. A wide range of commercial cleaning monitoring tests are available for WDs, but it is difficult to compare the efficacy of one WD cleaning monitor to another as there are no current standardized criteria for such tests; for example, what level of defect in detergent concentration, temperature, water quality, or spray-arm water impingement pressure will cause the cleaning monitor to fail? More research is needed to establish standardized criteria for WD cleaning monitors so guidelines can be developed. Despite this limitation, the use of such cleaning monitors does ensure that there is regular monitoring of WD cleaning efficacy within the constraints of the cleaning monitor used.
機(jī)洗時(shí)的清洗質(zhì)量可以通過監(jiān)測(cè)洗消機(jī)參數(shù)或者檢測(cè)處理后的器械來評(píng)估。目前的指南建議，應(yīng)至少每周進(jìn)行清洗效果的監(jiān)測(cè)，最好是每天。對(duì)于單臺(tái)自動(dòng)洗消機(jī)的檢測(cè)方式較多，但目前缺乏標(biāo)準(zhǔn)化的測(cè)試來比較不同洗消機(jī)之間的差異，如：清洗劑濃度、溫度、水質(zhì)或旋轉(zhuǎn)噴淋臂水沖擊壓力等方面什么程度的缺陷會(huì)導(dǎo)致清洗監(jiān)測(cè)呈現(xiàn)不合格？需要更多的研究來建立清洗監(jiān)測(cè)標(biāo)準(zhǔn)，以便制定指導(dǎo)方針。
Rapid cleaning monitoring tests can detect organic residuals such as TOC, protein, hemoglobin, and carbohydrate on the surface of surgical instruments. The ninhydrin test for protein has been evaluated for monitoring surgical instruments; however, this test does not detect all proteins and there are many false negative results, so it has not been widely implemented. Recently, ATP testing has been used to demonstrate that the cleaning of ultrasound probes requires improvement. Although rapid ATP tests have been used to assess cleaning adequacy for surgical instruments and ultrasound probes, more clinical studies are needed to establish the cut-off level of ATP (often measured as relative light units [RLUs]) for each test kit that reliably indicates that adequate cleaning has been achieved.
快速清洗監(jiān)測(cè)可以檢測(cè)到手術(shù)器械表面的有機(jī)殘留物，如TOC、蛋白質(zhì)、血紅蛋白和碳水化合物。茚三酮蛋白檢測(cè)已被用于監(jiān)測(cè)手術(shù)器械；然而，這種檢測(cè)并不能檢測(cè)到所有的蛋白質(zhì)，并且存在很多假陰性的結(jié)果，因此還沒有得到廣泛的應(yīng)用。最近，ATP檢測(cè)在清洗監(jiān)測(cè)的應(yīng)用較多，但同樣需要更可靠的數(shù)據(jù)支撐。
文章翻譯自 Alfa M . Medical instrument reprocessing: current issues with cleaning and cleaning monitoring.[J]. American journal of infection control, 2019, 47S:A10-A16.
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